PEMD方案治疗初治早期非上呼吸道消化道或晚期ENKTL患者的有效性及安全性分析  

Efficacy and safety of PEMD regimen in newly diagnosed early-stage non-upper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma

作　　者：张心怡 杜凯欣 申浩睿 吴佳竹[1] 李悦[1] 尹华 王莉[1] 梁金花[1] 李建勇[1] 徐卫[1] Zhang Xinyi;Du Kaixin;Shen Haorui;Wu Jiazhu;Li Yue;Yin Hua;Wang Li;Liang Jinhua;Li Jianyong;Xu Wei(The First Affiliated Hospital of Nanjing Medical University(Department of Hematology,Jiangsu Province Hospital),Nanjing 210029,China)

机构地区：[1]南京医科大学第一附属医院(江苏省人民医院)血液科,南京210029

出　　处：《中华血液学杂志》2025年第2期147-151,共5页Chinese Journal of Hematology

基　　金：国家自然科学基金(82200887、82370194);江苏省科技厅项目(BK20220716、BE2023780);中国博士后科学基金(2022M7114034、2023M741463)。

摘　　要：目的探讨PEMD(培门冬酶+依托泊苷+甲氨蝶呤+地塞米松)方案治疗初治早期非上呼吸道消化道或晚期结外NK/T细胞淋巴瘤(ENKTL)患者的疗效及安全性。方法回顾性分析纳入2016年1月至2022年12月于南京医科大学第一附属医院血液科诊断为初治早期非上呼吸道消化道或晚期ENKTL,且接受PEMD方案诱导化疗的38例患者。采用Kaplan-Meier法计算无进展生存(PFS)和总生存(OS)率,采用Log-rank检验比较组间生存差异,进行生存和预后因素分析。结果男30例(78.9%),女8例(21.1%);中位年龄48(26~72)岁。7例(18.4%)年龄>60岁,7例(18.4%)美国东部肿瘤协作组(ECOG)体能评分>1分,20例(52.6%)LDH水平升高,37例(97.4%)出现鼻部以外的结外组织受累,37例(97.4%)Ann Arbor分期为Ⅲ~Ⅳ期。患者中位治疗5(1~6)个周期,中位随访时间为60(24~101)个月。所有患者治疗结束时的总有效率为52.7%。2年和4年的PFS率分别为34.2%(95%CI 22.0%~53.2%)和25.5%(95%CI 14.7%~44.4%),2年及4年OS率分别为50.0%(95%CI 36.4%~68.7%)及45.5%(95%CI 31.4%~65.7%)。ECOG体能评分>1分[HR=3.711(95%CI 1.494~9.218),P=0.005]、骨髓浸润[HR=2.251(95%CI 1.026~4.938,P=0.043)]及PINK-E评分3~5分[HR=2.350(95%CI 1.009~5.476),P=0.048]为PFS的危险因素,多因素分析ECOG体能评分>1分为PFS的独立危险因素[HR=7.971(95%CI 2.222~28.591),P=0.001]。安全性评估显示,主要的不良反应为贫血(31例,81.6%)。结论PEMD方案对治疗初治早期非上呼吸道消化道或晚期ENKTL患者是安全有效的。ObjectiveTo evaluate the efficacy and safety of the pegaspargase,etoposide,methotrexate,and dexamethasone(PEMD)regimen in patients with early-stage nonupper respiratory digestive tract or advanced extranodal natural killer/T-cell lymphoma(ENKTL).MethodsThis retrospective analysis included 38 patients with newly diagnosed early-stage non-upper respiratory digestive tract or advanced ENKTL who received PEMD regimen for induction chemotherapy at the First Affiliated Hospital of Nanjing Medical University from January 2016 to December 2022.Survival outcomes and prognostic factors were examined by Kaplan-Meier,and the Log-rank test was used to compare survival.ResultsThe study population had a median age of 48 years(range,26-72 years)and included 30 males(78.9%)and 8 females(21.1%).7 patients’age>60 years(18.4%).The Eastern Cooperative Oncology Group(ECOG)performance score was>1 in 7 patients(18.4%);20 patients(52.6%)had elevated lactate dehydrogenase levels;and 37 patients(97.4%)exhibited extranodal involvement.Using the Ann Arbor staging system,37 patients(97.4%)were classified as stageⅢ-Ⅳ.The median number of treatment cycles was 5(1-6),and the median follow-up duration was 60 months(24-101 months).Interim efficacy assessment revealed an overall response rate of 52.7%.At 2 and 4 years,the progression-free survival(PFS)rates were 34.2%(95%CI 22.0%-53.2%)and 25.5%(95%CI 14.7%-44.4%),respectively,and the overall survival rates were 50.0%(95%CI 36.4%-68.7%)and 45.5%(95%CI 31.4%-65.7%),respectively.The risk factors for worse PFS were ECOG performance score>1[HR=3.711(95%CI 1.494-9.218),P=0.005];bone marrow infiltration[HR=2.251(95%CI 1.026-4.938),P=0.043];and Prognostic Index for Natural Killer/T-Cell Lymphoma score of 3-5[HR=2.350(95%CI 1.009-5.476),P=0.048].Multivariate analysis identified ECOG performance score>1 as an independent risk factor for PFS[HR=7.971(95%CI 2.222-28.591),P=0.001].The main adverse effect was anemia in 31 patients(81.6%).ConclusionThe PEMD regimen was safe and effective for patients with

关 键 词：淋巴瘤 结外NK/T细胞 培门冬酶 生存分析 

分 类 号：R733.1[医药卫生—肿瘤]